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NCT03995485

KW-136 With Sofosbuvir for Chinese Adults With Chronic Hepatitis C

Evaluation of Efficacy and Safety of KW-136 Capsule Combined With Sofosbuvir Tablet for Treatment of Adult Chronic Hepatitis C: an Open-label, Multi-center, Phase 3 Study
Kawin Technology Share-holding Co., Ltd.·Phase 3·ClinicalTrials.gov·drugCompleted
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Study focus
Disease/Condition
Hepatitis C, Chronic
Drug/Device/Intervention
KW-136 capsule
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Kawin Technology Share-holding Co., Ltd.
Location
Beijing,Beijing,Beijing,Beijing,Chongqing,Wanzhou,Guangzhou,Guanzhou,Liuzhou,Zhengzhou,Wuhan,Nanjing,Changchun,Yanbian,Shenyang,Xi'an,Ji'nan,Chengdu,Ürümqi, China
Timeline & enrollment
Phase
Phase 3
Start date
Jun 07, 2017
End date
Mar 07, 2018
Enrollment
371 participants
Primary outcome

Sustained virologic response at 12 weeks after end of treatment (SVR12)

Summary

This study aimed to confirm efficacy and safety of KW-136, an investigational anti-hepatitis
 C virus (HCV) drug, combined with sofosbuvir for treatment of naive and experienced adults
 chronically infected with HCV. Three hundred and sixty (360) non-cirrhotic and cirrhotic
 subjects were medicated with KW-136 60 mg daily and sofosbuvir 400 mg daily. The treatment
 course lasted 12 successive weeks; thereafter all the study participants entered into a
 12-week treatment-free follow-up period and an additional 12-week extension treatment-free
 follow-up period.

ICD-10 classifications
Chronic viral hepatitis CAcute hepatitis CChronic hepatitis, unspecifiedChronic viral hepatitisChronic viral hepatitis, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT03995485
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT03995485 through Pure Global AI's free database. This Phase 3 trial is sponsored by Kawin Technology Share-holding Co., Ltd. and is currently Completed. The study focuses on Hepatitis C, Chronic. Target enrollment is 371 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.